The present invention relates to a device for creating and maintaining an artificial stoma enabling access to a body cavity, such as used in the direct feeding of a patient's stomach. More particularly, the present invention relates to a device for percutaneously placing various gastric catheters, forming artificial stomas capable of accessing the gastrointestinal tract, and ultimately providing a gastric feeding capability. Beyond the initial placement procedure, the device meets the requirements for permanent placement in the patient, such that when used for enteral feeding, the device enables a low-force, dynamically self-adjusting, directed seal between the inside of the stomach or gastric wall and an external body surface, i.e., the outside of the abdominal wall.
In particular, the invention addresses the problem of the seal or permanent fusion of the tissues surrounding the stoma that needs to be established between the abdominal cavity and the inside of the stomach immediately after the surgical creation of the fistula, i.e., during the initial insertion of the catheter. It also is concerned with ways in which subsequent to placement, the catheter can be changed simply and atraumatically, even by a trained layperson, without damaging the stoma site.
It is recognized that numerous medical conditions exist in which it becomes necessary to gain percutaneous access to viscera such as the stomach or small intestines. Situations where a patient has lost the ability to swallow and will require long term nutritional support may dictate feeding directly into the stomach or jejunum. Feeding in this manner may be accomplished by inserting a feeding tube into the patient's stomach such that one end remains anchored in the stomach, while the other end remains external to the patient's body for connection to a nutrient source. A variety of different feeding tubes or catheters intended for enteral feeding have been developed over the years, including some having a “low profile” relative to the patient during use and those having the more traditional or non-low profile configuration.
Such feeding tubes may be inserted into a patient's stomach in a number of ways. Feeding tubes may be endoscopically placed, surgically placed through an open incision, laproscopically placed, or percutaneously placed under endoscopic, fluoroscopic or ultrasonic guidance. Different types of feeding tubes may be placed using these procedures, examples include gastrostomy, jejunostomy or gastro-jejunostomy. These tubes may be retained in the lumen (stomach or intestine) with a variety of retention anchors. These anchoring mechanisms include: inflatable balloons, obturatable domes, fixed dome-type bumpers, or suture wings.
It is known that many of the catheters on the market today are commonly referred to as “replacement” catheters because they are substituted for an enteral feeding tube that is initially placed in a patient for six to eight weeks until a fistula stoma tract is established. Once the stoma tract is established, the initial placement device is generally removed, and the “replacement” enteral feeding device is inserted into the stoma tract. Historically, prior to placing the actual enteral feeding device, it has been preferred to perform a gastropexy procedure during placement. This procedure enables the physician to attach the visceral wall to the abdomen and to create the stoma tract through the two. This attachment is critical to prevent inadvertent separation and exposure of the peritoneal cavity to contamination and possible peritonitis.
Initial placement devices are often not readily removable without additional invasive surgical procedures. That is, many initially placed enteral catheters contain rigid retention members which cannot readily be passed through the stoma of the patient when it is desired to remove the initially placed device. Typically the t-shaped fastener or t-bar is not removable and is left in the body cavity where it is allowed to pass naturally in the patient's stool. In many cases the t-bar is not passed and remains within the body cavity. Moreover, during the six to eight weeks it takes for the fistula's stoma tract to be established, the anchoring mechanism of the prior art gastropexy device which typically consists of a small metal t-shaped fastener may embed itself into the gastric or intestinal wall and ultimately lead to infection. Furthermore, the t-bar itself may have sharp edges which can be uncomfortable for the patient.
In many of these procedures, in order to achieve the desired seal between the stomach and the abdominal wall, a traction force must be applied to the anchoring mechanism. The force is applied in such a way as to pull the stomach cavity to the abdominal wall so that the penetration through both may heal together thereby creating the passage or stoma leading from the patient's stomach, through the abdominal wall, to an external environment. It is necessary to apply this traction force for a period of a couple of days through a couple of weeks until the stoma site adequately heals. During this period the patient has reduced mobility which may lead to additional post-operative complications.
There is a need and desire for a device which may be used during initial placement or creation of a stoma site and which also may serve as the “replacement” enteral feeding device itself Such a device would foster the permanent fusion of the stomach wall to the abdomen; it would replace standard catheter placement technology and thus substitute a single step procedure for the standard multi-step procedure. This would serve to reduce the invasiveness of the procedure, greatly enhance wound healing, and enable immediate, post-placement gastric access for feeding and drainage, and ultimately allow atraumatic exchange of the low profile device.